This invention relates generally to medical devices and methods of use, and more specifically, to materials, apparatus, and methods for facilitating hemostasis within a body cavity or passageway.
Nasal passageways, for example, are often susceptible to uncontrolled bleeding caused by various forms of trauma, disease or cellular dysfunction. Methods and devices for controlling, limiting or stopping such bleeding would be useful in a variety of situations, ranging from emergency room care to long term care.
Treatment of intestinal diverticular disease would also be facilitated by methods and devices for the prevention and control of bleeding in such diverticula. However, diverticula present a problem in many cases even if they have not advanced to the stage where they bleed. Diverticula are sacral pockets or protrusions in the intestinal tract, derived from the intestinal lumen and of varying sizes, occurring normally through a defect in the muscular coating of the tract.
As shown in FIG. 17, the diverticula of the colon are usually multiple and may be accompanied by inflammation. In the absence of inflammation, the condition is known as diverticulosis, while in the presence of inflammation, the condition is referred to as diverticulitis. Although the distinction between the two conditions is clear when a colon is examined surgically or histologically, the symptoms of colonic dysfunction due to diverticulosis sometimes mimic those of diverticulitis and, therefore, the clinical distinction between the two conditions may often be blurred. Consequently, diverticular disease of the colon typically refers to all stages of the disease from diverticulosis.
Typically, globular diverticula communicate with the bowel lumen via a narrow neck through which gas can pass freely. They are prone to filling with fecal material extruded through the lumen that may then become firm. Such a process usually begins in the Sigmoid area of the colon and then typically spreads proximally throughout the intestinal tract over the course of several years. Infection and inflammation occurs in approximately 15-25% of patients with diverticulosis.
Complications associated with diverticular disease include sepsis, fistula, bleeding, obstruction, obstruction, and intractable painful disturbance of the bowel function, with typical septic complications being abscess and perforation accompanied with diffuse bacterial and/or feculent peritonitis. One of the most dangerous complications of diverticular disease is that of bleeding diverticula.
Diverticula usually form at a site where an artery supplying blood to mucosa penetrates the muscular wall of the colon. The penetration of the muscular wall causes a xe2x80x9cweak pointxe2x80x9d and a diverticulum may form, with the result that the artery terminates in the mucosa inside the diverticulum. If the diverticulum becomes infected, or if compacted fecal matter causes an irritation, then the end of the artery may fail causing excessive bleeding. As this bleeding is arterial, it is generally very difficult to control, and major surgery involving the forming of a colostomy and a later (few months) reconnecting the colon or removing a section of the colon is often the only available treatment.
Hemostatic agents, such as carboxymethyl cellulose (CMC) and woven knit or matted fabrics thereof, are known for use in the control of bleeding, such as post-trauma and post-surgical bleeding. CMC is defined as a polycarboxylmethyl ether of cellulose or the sodium salt thereof. It is sometimes referred to cellulose ether, carboxymethylcellulose, or sodium caramellose.
The present invention comprises methods, apparati, and devices for the control of bleeding from an inner wall of a body passageway or cavity and for the plugging or closure of pathological cavities.
Briefly, the invention comprises an inflatable, expandable balloon, usually covered by a hemostatic shroud, which is inserted into a body cavity, such as a nasal passageway or intestinal diverticula. The shroud is composed of a fabric which exhibits hemostatic properties; that is, the shroud acts to facilitate or enhance blood clot formation. The balloon component of the present invention is expanded, or inflated, within the cavity in order to press the shroud against the site of bleeding, thereby allowing it to absorb blood and facilitate hemostasis. In specific embodiments, the shroud is composed of a woven or knitted fabric of a hemostatic fiber (such as carboxymethylcellulose) or a reinforced hemostatic fiber. Optionally, this shroud may include an xe2x80x9cextensionxe2x80x9d or xe2x80x9ctailxe2x80x9d fiber, which upon balloon deflation and removal, facilitates the later removal of the shroud which has been intentionally left in vivo.
The device construction, particularly the balloon construction, may vary according to the particular body cavity. Although a range of different materials can be used for any of the embodiments, there are particular materials which work better than others, depending upon the particular application. For example, for a diverticula, the balloon is made of a highly elastic material such as silicone rubber. For a nasal application, however, the preferred construction is an inflatable, but non-stretchable, balloon made from a relatively inelastic material.
The invention also includes a method and device for controlling bleeding on an inner wall of a body cavity or passageway. The method comprises the step of inserting into a cavity a first inflatable balloon surrounded at least in part by a hemostatic shroud comprising a gel-forming absorbent composition. The expandable balloon is then expanded (inflated) which compresses the shroud against the inner surface of the cavity where bleeding is to be controlled. In nasal embodiments, during expansion of the expandable balloon and shroud, the pressure inside the expandable balloon can be monitored by touching a pressure-indicating pilot balloon which is in fluid communication with the first expandable balloon. The external tactile pressure sensing pilot balloon is located so that it does not enter the passageway. This allows a user to feel the pressure within the system as the first expandable balloon is inflated and permits monitoring of the first expandable balloon to avoid under-inflation or over-inflation. In the embodiment where the pilot cuff is used, a preferred pilot balloon is inflatable but non-stretchable, and has a fixed maximum volume.
Other aspects of the invention comprise methods for controlling bleeding in body passageways involving use of the devices described above.
A particular embodiment of the invention comprises a device for insertion of a shrouded balloon into a nasal passageway by a catheter configured such that the balloon encircles the catheter tube. The lumen of the catheter tube thereby serves as a passageway for breathing. The inflated balloon compresses the shroud against the bleeding nasal wall, thereby facilitating or enhancing hemostasis. The balloon is deflatable such that, upon balloon deflation, the shroud may be left in place on the cavity wall and may be removed at a later time, such as by an attached extension on the shroud.
In another embodiment, there is no central lumen. This gives the catheter a much smaller overall diameter. In patients with small nasal cavities, the lack of the breathing passageway is more than compensated for by the small profile which is far less traumatic and painful during insertion.
The shroud used in the present invention may comprise a woven or knitted fabric combining hemostatic (e.g., carboxymethylcellulose (CMC)) fibers with reinforcing fibers.
The invention also comprises methods and devices for the plugging of a cavity, such as a diverticulum, consisting of a catheter for the delivery and insertion into the cavity of a filling material, the filling material itself which is releasably connected to the catheter, and marker material for indicating the site of a cavity which has been plugged. Some examples of appropriate filling material include balloons which are designed to resist deflation, curable material, fibrous material, and resiliently deformable members. An anchor apparatus may be necessary in plugging a cavity if there is a chance that the filler material will be expelled by the peristaltic action of the digestive tract. These devices and methods may be used either to address a pathological situation or to act preemptivelyxe2x80x94i.e., to check the progression of diverticulosis to diverticulitis.